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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

It was concluded that H-MI is not mutagenic in the bacterial reverse mutation assay (JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals) carried out under the experimental conditions.

The test material did not induce any statistically significant, dose-related increases in the frequency of cells with structural or numerical chromosome aberrations either in the presence or absence of a liver enzyme metabolising system or after various exposure times. The test material was therefore considered to be non-clastogenic to CHL cells in vitro (OECD Guideline 473 (In vitro Mammalian Chromosome Aberration Test)).

Short description of key information:
Two genetic toxicity studies have been conducted on the test material H-MI ammonium salt, both in vitro (Ames and Chromesome abberration).

All studies have been ranked 'reliability 1' according to the Klimisch et al scale as they were conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative results were indicated in both of the genetic toxicity studies.